[Federal Register Volume 67, Number 247 (Tuesday, December 24, 2002)]
[Rules and Regulations]
[Pages 78354-78356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32345]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 524


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 25 approved new 
animal drug applications (NADAs) from American Cyanamid to Fort Dodge 
Animal Health.

DATES: This rule is effective December 24, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: American Cyanamid, Division of American Home 
Products, P.O. Box 1339, Fort Dodge, IA 50501, has informed FDA that it 
has transferred ownership of, and all rights and interest in, the 
following 25 approved NADAs to Fort Dodge Animal Health, Division of 
American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501:

------------------------------------------------------------------------
     NADA  Number                          Trade Name
------------------------------------------------------------------------
006-084                SULMET Drinking Water
                       Solution
008-774                SULMET Solution Injectable
011-582                VETAMOX Soluble Powder
011-644                FELAC
013-957                S.E.Z. Drinking Water 6.25%
015-160                Sodium Sulfachloropyrazine
                       Solution
033-342                PROBAN Cythioate Tablets 30 mg
033-606                PROBAN Oral Liquid
033-653                S.E.Z. Drinking Water Solution
033-654                S.E.Z. Oblets 15 g
033-655                S.E.Z. Intravenous Solution
047-033                S.E.Z. C-R Oblets 15 g
055-012                AUREOMYCIN Sulmet Soluble Powder
055-018                AUREOMYCIN Tablets 25 mg
055-020                AUREOMYCIN Soluble Powder
055-039                AUREOMYCIN Soluble Oblets
065-071                AUREOMYCIN Soluble Powder
065-269                POLYOTIC Soluble Powder
065-270                POLYOTIC Oblets
065-313                BACIFERM Soluble 50
065-440                AUREOMYCIN Soluble Powder Concentrate
065-441                POLYOTIC Soluble Powder Concentrate
122-271                SULMET Oblets
122-272                SULMET Soluble Powder

[[Page 78355]]

 
140-844                TRAMISOL Pour-On
------------------------------------------------------------------------

Accordingly, the agency is amending the regulations in 21 CFR 520.44, 
520.154c, 520.445a, 520.445b, 520.445c, 520.530, 520.531, 520.2184, 
520.2240a, 520.2240b, 520.2260a, 520.2261a, 520.2261b, 520.2345c, 
520.2345d, 522.940, 522.2240, 522.2260, and 524.1240 to reflect the 
transfer of ownership and to reflect current format.
    Following this change of sponsorship, American Cyanamid is no 
longer the sponsor of any approved application. Accordingly, 21 CFR 
510.600(c) is being amended to remove the entries for American 
Cyanamid.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
520, 522, and 524 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``American Cyanamid'' and in the table 
in paragraph (c)(2) by removing the entry for ``010042''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.44  [Amended]

    4. Section 520.44 Acetazolamide sodium soluble powder is amended in 
paragraph (b) by removing ``010042'' and by adding in its place 
``053501''.


Sec.  520.154c  [Amended]

    5. Section 520.154c Bacitracin zinc soluble powder is amended in 
paragraph (b) by removing ``010042'' and by adding in its place 
``053501''.


Sec.  520.445a  [Amended]

    6. Section 520.445a Chlortetracycline bisulfate/sulfamethazine 
bisulfate soluble powder is amended in paragraph (b) by removing 
``010042'' and by adding in its place ``053501''.


Sec.  520.445b  [Amended]

    7. Section 520.445b Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfate) is amended in paragraphs 
(b) and (d)(4)(iii)(C) by removing ``010042'' and by adding in its 
place ``053501''.


Sec.  520.445c  [Amended]

    8. Section 520.445c Chlortetracycline tablets and boluses is 
amended in paragraph (b) by removing ``010042'' and by adding in its 
place ``053501''.


Sec.  520.530  [Amended]

    9. Section 520.530 Cythioate oral liquid is amended in paragraph 
(b) by removing ``010042'' and by adding in its place ``053501''.


Sec.  520.531  [Amended]

    10. Section 520.531 Cythioate tablets is amended in paragraph (b) 
by removing ``010042'' and by adding in its place ``053501''.


Sec.  520.2184  [Amended]

    11. Section 520.2184 Sodium sulfachloropyrazine monohydrate is 
amended in paragraph (b) by removing ``010042'' and by adding in its 
place ``053501''.


Sec.  520.2240a  [Amended]

    12. Section 520.2240a Sulfaethoxypyridazine drinking water is 
amended in paragraph (c) by removing ``010042'' and by adding in its 
place ``053501''.


Sec.  520.2240b  [Amended]

    13. Section 520.2240b Sulfaethoxypyridazine tablets is amended in 
paragraph (c) by removing ``010042'' and by adding in its place 
``053501''.


Sec.  520.2260a  [Amended]

    14. Section 520.2260a Sulfamethazine oblet, tablet, and bolus is 
amended in paragraph (a)(1) by removing ``010042'' and by adding in its 
place ``053501''.


Sec.  520.2261a  [Amended]

    15. Section 520.2261a Sulfamethazine sodium drinking water solution 
is amended in paragraph (a) by removing ``010042'' and by adding in its 
place ``053501''.


Sec.  520.2261b  [Amended]

    16. Section 520.2261b Sulfamethazine sodium soluble powder is 
amended in paragraph (a) by removing ``010042'' and by adding in its 
place ``053501''.


Sec.  520.2345c  [Amended]

    17. Section 520.2345c Tetracycline boluses is amended in paragraph 
(b) in the first sentence by removing ``010042'' and by adding in its 
place ``053501''.


Sec.  520.2345d  [Amended]

    18. Section 520.2345d Tetracycline hydrochloride soluble powder is 
amended in paragraphs (a)(3), (d)(1)(iii), and (d)(2)(iii) by removing 
``010042'' and by adding in its place ``053501''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    19. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  522.940  [Amended]

    20. Section 522.940 Colloidal ferric oxide injection is amended in 
paragraph (c)(1) by removing ``010042 and 017800'' and by adding in its 
place ``017800 and 053501''.


Sec.  522.2240  [Amended]

    21. Section 522.2240 Sulfaethoxypyridazine is amended in paragraph 
(c) by removing ``010042'' and by adding in its place ``053501''.


Sec.  522.2260  [Amended]

    22. Section 522.2260 Sulfamethazine injectable solution is amended 
in paragraph (b) by removing ``010042'' and by adding in its place 
``053501''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    23. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  524.1240  [Amended]

    24. Section 524.1240 Levamisole is amended in paragraph (b) by 
removing ``010042'' and by adding in its place ``053501''.


[[Page 78356]]


    Dated: November 8, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-32345 Filed 12-23-02; 8:45 am]
BILLING CODE 4160-01-S